BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 16819843 · Received April 26, 2023

    Report

    Report Number
    3002808148-2023-04225
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Report Date
    June 29, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THIRD-PARTY TESTING (PLEASE SEE B6) AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE INSTRUCTION MANUAL OF BF-UC180F DESCRIBES THE REPROCESSING METHODS IN THE FOLLOWING CHAPTERS: CHAPTER "COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS" CHAPTER "CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES" OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    INITIAL DEVICE EVALUATION REVEALED THE FOLLOWING FINDINGS: THE DISTAL END PLASTIC COVER HAD A DENT, AND THE ADHESIVE ON BENDING SECTION COVER (A-RUBBER) HAD A CHIP. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. INITIAL TESTING REPORTED, THAT NO MICROORGANISMS WERE DETECTED. THE MICROBIOLOGICAL ANALYSIS RESULTS ARE PENDING. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE SCOPE WAS SAMPLED TWO TIMES. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR 80,000 KOLONIEBILDENDE EINHEIT (KBE)/ US CONVERSION - COLONY FORMING UNITS (CFUS) OF DERMACOCCUS BARATHRI. THE ISSUE WAS FOUND AT REPROCESSING IN THE RINSING/IRRIGATION FLUID. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE POSITIVE CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404431 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown